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Safety and immunogenicity of haemophilus influenzae type B polysaccharide or conjugate vaccines in an elderly adult population.
J Am Geriatr Soc. 2004 Nov; 52(11):1883-7.JA

Abstract

OBJECTIVES

To evaluate the safety and immunogenicity of unconjugated Haemophilus influenzae type b (Hib) polysaccharide (PRP) vaccine and two PRP-protein-conjugated vaccines as a model for the comparison of protein-conjugated versus plain polysaccharide vaccines in the elderly.

DESIGN

Randomized, double-blind, prospective study.

SETTING

University-based center for vaccine research and development.

PARTICIPANTS

A total of 125 adults, aged 64 to 92, who were judged to be in general good health and lacking any significant underlying medical conditions.

INTERVENTION

Subjects were randomized to receive one of three vaccines: Group 1 (n=39), PRP; Group 2 (n=44), PRP conjugated to an outer-membrane protein complex of Neisseria meningitidis (PRP-OMP); and Group 3 (n=42), PRP conjugated to diphtheria toxoid (PRP-D). Sera were obtained before immunization and 1 and 12 months later.

MEASUREMENTS

Subjects maintained a diary of injection site and systemic reactions for 3 days after immunization. A radioantigen-binding assay was used to measure total concentrations of serum anticapsular antibody, and an enzyme-linked immunosorbent assay was used to measure immunoglobulin (Ig) G1 and IgG2 anticapsular antibody responses. Antibody functional activity was assessed using a complement-mediated bactericidal assay.

RESULTS

Before vaccination, the geometric mean serum anticapsular antibody concentration was 0.8 microg/mL, but fewer than 10% of subjects had detectable bactericidal activity (titer>1:4). The magnitude, subclass distribution, and bactericidal activity of antibody responses to unconjugated PRP vaccine were similar to those observed in previous studies of younger adults immunized with PRP. The OMP conjugate, which is highly immunogenic after one dose in 2-month old infants, did not elicit anticapsular antibody responses in the elderly greater than those elicited by PRP vaccine (P=.43). In contrast, the D conjugate, which is poorly immunogenic in 2-month old infants, elicited higher anticapsular antibody responses than PRP vaccine in the elderly (P=.01) and higher levels than the OMP-conjugate 1 year after vaccination (P<.006).

CONCLUSION

Elderly adults develop protective anticapsular antibody responses to unconjugated and conjugated PRP vaccine. The higher anticapsular antibody responses to the D conjugate but not to the OMP conjugate in the elderly, which is the reverse of that observed in immunized infants, implies fundamental differences in the immunological mechanisms by which the two age groups respond to PRP and by which the OMP and D conjugates elicit anticapsular antibody responses.

Authors+Show Affiliations

Department of Internal Medicine, Division of Infectious Diseases and Immunology, Saint Louis University Health Science Center, 3635 Vista Avenue at Grand, PO Box 15250, Saint Louis, MO 63110, USA. lottenkr@slu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15507066

Citation

Lottenbach, Kathleen R., et al. "Safety and Immunogenicity of Haemophilus Influenzae Type B Polysaccharide or Conjugate Vaccines in an Elderly Adult Population." Journal of the American Geriatrics Society, vol. 52, no. 11, 2004, pp. 1883-7.
Lottenbach KR, Granoff DM, Barenkamp SJ, et al. Safety and immunogenicity of haemophilus influenzae type B polysaccharide or conjugate vaccines in an elderly adult population. J Am Geriatr Soc. 2004;52(11):1883-7.
Lottenbach, K. R., Granoff, D. M., Barenkamp, S. J., Powers, D. C., Kennedy, D., Irby-Moore, S., Homan, S. M., & Mink, C. M. (2004). Safety and immunogenicity of haemophilus influenzae type B polysaccharide or conjugate vaccines in an elderly adult population. Journal of the American Geriatrics Society, 52(11), 1883-7.
Lottenbach KR, et al. Safety and Immunogenicity of Haemophilus Influenzae Type B Polysaccharide or Conjugate Vaccines in an Elderly Adult Population. J Am Geriatr Soc. 2004;52(11):1883-7. PubMed PMID: 15507066.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of haemophilus influenzae type B polysaccharide or conjugate vaccines in an elderly adult population. AU - Lottenbach,Kathleen R, AU - Granoff,Dan M, AU - Barenkamp,Stephen J, AU - Powers,Douglas C, AU - Kennedy,Donald, AU - Irby-Moore,Sharon, AU - Homan,Sharon M, AU - Mink,ChrisAnna M, PY - 2004/10/28/pubmed PY - 2004/12/16/medline PY - 2004/10/28/entrez SP - 1883 EP - 7 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 52 IS - 11 N2 - OBJECTIVES: To evaluate the safety and immunogenicity of unconjugated Haemophilus influenzae type b (Hib) polysaccharide (PRP) vaccine and two PRP-protein-conjugated vaccines as a model for the comparison of protein-conjugated versus plain polysaccharide vaccines in the elderly. DESIGN: Randomized, double-blind, prospective study. SETTING: University-based center for vaccine research and development. PARTICIPANTS: A total of 125 adults, aged 64 to 92, who were judged to be in general good health and lacking any significant underlying medical conditions. INTERVENTION: Subjects were randomized to receive one of three vaccines: Group 1 (n=39), PRP; Group 2 (n=44), PRP conjugated to an outer-membrane protein complex of Neisseria meningitidis (PRP-OMP); and Group 3 (n=42), PRP conjugated to diphtheria toxoid (PRP-D). Sera were obtained before immunization and 1 and 12 months later. MEASUREMENTS: Subjects maintained a diary of injection site and systemic reactions for 3 days after immunization. A radioantigen-binding assay was used to measure total concentrations of serum anticapsular antibody, and an enzyme-linked immunosorbent assay was used to measure immunoglobulin (Ig) G1 and IgG2 anticapsular antibody responses. Antibody functional activity was assessed using a complement-mediated bactericidal assay. RESULTS: Before vaccination, the geometric mean serum anticapsular antibody concentration was 0.8 microg/mL, but fewer than 10% of subjects had detectable bactericidal activity (titer>1:4). The magnitude, subclass distribution, and bactericidal activity of antibody responses to unconjugated PRP vaccine were similar to those observed in previous studies of younger adults immunized with PRP. The OMP conjugate, which is highly immunogenic after one dose in 2-month old infants, did not elicit anticapsular antibody responses in the elderly greater than those elicited by PRP vaccine (P=.43). In contrast, the D conjugate, which is poorly immunogenic in 2-month old infants, elicited higher anticapsular antibody responses than PRP vaccine in the elderly (P=.01) and higher levels than the OMP-conjugate 1 year after vaccination (P<.006). CONCLUSION: Elderly adults develop protective anticapsular antibody responses to unconjugated and conjugated PRP vaccine. The higher anticapsular antibody responses to the D conjugate but not to the OMP conjugate in the elderly, which is the reverse of that observed in immunized infants, implies fundamental differences in the immunological mechanisms by which the two age groups respond to PRP and by which the OMP and D conjugates elicit anticapsular antibody responses. SN - 0002-8614 UR - https://www.unboundmedicine.com/medline/citation/15507066/Safety_and_immunogenicity_of_haemophilus_influenzae_type_B_polysaccharide_or_conjugate_vaccines_in_an_elderly_adult_population_ DB - PRIME DP - Unbound Medicine ER -